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NCT06491953Active, not recruiting

SGLT2-inhibitors on PC-AKI

Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy

Source: ClinicalTrials.gov · Last updated 10 Sept 2025

Brief summary (registry, in English)

Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI). Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR). Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
3600 (estimated)
First submitted
1 Jul 2024
Start date
1 Jun 2024
Primary completion date
30 May 2025
Lead sponsor
Shenyang Northern Hospital
NCT number
NCT06491953

What you commit to

  • Study type: Observational
  • Planned participants: 3600
  • From 1 Jun 2024 to the primary completion date, 30 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Administration of any iodinated CM within 14 days before CAG or PCI

Other illness

  • Thyreoid insufficiency
  • Known allergy to any of the study drugs or devices (iodinated CM, etc.)
  • Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators

Lab values

  • Hepatic dysfunction (ALT 3 times greater than upper normal limit)
  • Contraindications for the use of SGLT-2 inhibitors, such as severe renal insufficiency (eGFR \<30 mL/min/1.73m2 or currently on dialysis), type 1 diabetes mellitus, severe infection, etc.)

Other

  • Renal artery Stenosis (unilateral \>70% or bilateral stenosis\>50%)
  • Pregnancy or lactation

Who the study is looking for

  • ACS patients undergoing invasive treatment (PCI or CAG)
  • 18 \~ 80 years old adult patients
  • Written informed consent provided

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
General Hospital of Northern Theater Command
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.